Method and apparatus for detecting substances using substance detection routines

ABSTRACT

Methods and devices for sampling, processing and identifying use of a substance or substances of abuse are provided. Systems and kits for sampling, processing and identifying acute use of a substance of abuse is also provided.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a Continuation of U.S. Patent Application No.16/790,457, filed Feb. 13, 2020; which is a Continuation of U.S. PatentApplication No. 15/958,616, filed Apr. 20, 2018, now U.S. Patent No.10,641,783, issued May 5, 2020; which is a Continuation of U.S. PatentApplication No. 14/641,412, filed Mar. 8, 2015, now U.S. Patent No.9,970,950, issued May 15, 2018; which claims the benefit of U.S.Provisional Patent Application No. 61/950,173, filed Mar. 9, 2014; allof the aforementioned priority applications being hereby incorporatedherein by reference for all purposes.

BACKGROUND

It is well known that operating a vehicle under the influence ofsubstances that impair operating conditions is dangerous. For example,dangers of driving a car under the influence of alcohol or drugs ofabuse are established. With alcohol, existing breathanalyzer often usedby law enforcement officers roadside can determine the level of alcoholin the driver’s system at the time of administering the breathalyzertest. However, no such device exists in the market place that can detectand quantify tetrahydrocannabinol (THC) levels-the principalpsychoactive constituent of cannabis-of suspected users operating avehicle when pulled over by a law enforcement officer roadside.

With legalization of marijuana expanding and the risk ofmarijuana-associated impaired driving increasing, there is a need for adevice that can quantify THC (and other substances of abuse) levels ofsuspected users roadside to establish recent or acute consumption or useof marijuana alone or in combination with other substances of abuse suchas alcohol, codeine, cocaine, morphine, or methamphetamine.

SUMMARY

The purpose and advantages of the present disclosure will be set forthin and apparent from the description that follows, as well as will belearned by practice of the disclosure. Additional advantages of thepresent disclosure will be realized and attained by the methods andsystems particularly pointed out in the written description and claimshereof, as well as from the appended drawings.

To achieve these and other advantages and in accordance with the purposeof the present disclosure, as embodied herein and broadly described, thepresent disclosure includes devices and methods for acute detection oftarget substance under analysis such that where acute detection of oneor more target substances provide confirmation of recent use oringestion of the target substance. For example, the detection devices ofthe various embodiments of the present disclosure provides confirmationof recent use or ingestion of one or more of cannabis, alcohol, codeine,cocaine, morphine, methamphetamine, or other substance of abuse.Embodiments of the present disclosure provide compact, handhelddetection devices for use such as in road-side testing by lawenforcement, testing in public and private locations such as schools(e.g., school dances), at home, or place of business, to determinewhether a person or persons is under the influence of one or more of thetarget substances.

Accordingly, in certain embodiments, there is provided a method thatincludes performing acquisition of a sample having a plurality ofanalysis substances, executing, using one or more processors, a firstsubstance detection routine and a second substance detection routine fordetecting the presence of the first analysis substance and the secondanalysis substance in the acquired sample, respectively; and generatingan output signal based on the executed first and second substancedetection routines, wherein the output signal corresponds to the acutedetection of target substance(s) in the sample.

A method in accordance with another embodiment includes performingacquisition of a sample having one or more analysis substances,executing, using one or more processors, a first substance detectionroutine and a second substance detection routine for detecting thepresence of the first analysis substance and the second analysissubstance in the acquired sample, respectively, generating an outputsignal based on the executed first and second substance detectionroutines, wherein the output signal corresponds to the presence in thesample of target substance associated with the one or more of theanalysis substances, where the second substance detection routine isperformed within a predetermined time period after the completion of thefirst substance detection routine, where the first analysis substance isthe same as the second analysis substance, and further, where the outputsignal confirms the acute detection of the target substance in theacquired sample when a determined gradient corresponds to apredetermined gradient, where the gradient is determined based on thelevel of the detected first analysis substance and the detected secondanalysis substance.

A method in still a further embodiment includes performing acquisitionof a sample having one or more analysis substances, executing, using oneor more processors, a first substance detection routine for detectingthe presence of the first analysis substance, a second substancedetection routine for detecting the presence of the first analysissubstance, and a third substance detection routine for detecting thepresence of the second analysis substance, and generating an outputsignal based on the executed first, second and third substance detectionroutines, wherein the output signal corresponds to the presence in thesample of target substance associated with the one or more of theanalysis substances, where the second substance detection routine isperformed within a predetermined time period after the completion of thefirst substance detection routine and further where the output signalconfirms acute detection of the target substance in the acquired samplewhen (1) a determined gradient of the first analysis substancecorresponds to a predetermined gradient profile, where the gradient isdetermined based on the level of the detected first analysis substancefrom the first substance detection routine and the second substancedetection routine, and (2) the presence of the second analysis substanceassociated with the target sample from the third substance detectionroutine is determined.

An apparatus in accordance with one embodiment includes one or moresampling modules configured to acquire one or more samples having one ormore analysis substances, a processing unit operatively coupled to theone or more sampling modules configured to execute a first substancedetection routine and a second substance detection routine for detectingthe presence of the first analysis substance and the second analysissubstance in the acquired one or more samples, respectively, and anoutput unit operatively coupled to the processing unit and configured tooutput one or more signals based on the executed first and secondsubstance detection routines, wherein the output signal corresponds toacute detection of target substance in the one or more samples. Incertain embodiments, the one or more sampling modules includes a singleuse replaceable cartridge that mate with the housing of the apparatusand is discarded after single use. More specifically, each cartridge incertain embodiments is used to acquire the sample (breath, saliva etc.),which is processed using one or more routines described herein todetermine the level of target substance(s) (THC, alcohol, or both THCand alcohol) in the acquired sample.

An apparatus in accordance with still yet further embodiment includesone or more sampling modules configured to acquire one or more sampleshaving one or more analysis substances, a processing unit operativelycoupled to the one or more sampling modules configured to execute afirst substance detection routine and a second substance detectionroutine for detecting the presence of the first analysis substance andthe second analysis substance in the acquired sample, respectively togenerate one or more signals based on the executed first and secondsubstance detection routines, wherein the generated one or more signalscorresponds to acute detection of target substance in the one or moresamples, where the second substance detection routine is performedwithin a predetermined time period after the completion of the firstsubstance detection routine, where the first analysis substance is thesame as the second analysis substance, and further, where the one ormore signals confirms the acute detection of the target substance in theacquired sample when a determined gradient corresponds to apredetermined gradient, where the gradient is determined based on thelevel of the detected first analysis substance and the detected secondanalysis substance.

An apparatus in yet still a further embodiment includes one or moresampling modules configured to acquire one or more samples having one ormore analysis substances, a processing unit operatively coupled to theone or more sampling modules configured to execute a first substancedetection routine for detecting the presence of the first analysissubstance, a second substance detection routine for detecting thepresence of the first analysis substance, and a third substancedetection routine for detecting the presence of the second analysissubstance, the processing unit further configured to generate an outputsignal based on the executed first, second and third substance detectionroutines, wherein the output signal corresponds to acute detection oftarget substance in the one or more samples, where the second substancedetection routine is performed within a predetermined time period afterthe completion of the first substance detection routine, and furtherwhere the output signal confirms acute detection of the target substancein the acquired sample when (1) a determined gradient of the firstanalysis substance corresponds to a gradient profile, where the gradientis determined based on the level of the detected first analysissubstance from the first substance detection routine and the secondsubstance detection routine, and (2) the presence of the second analysissubstance associated with the target sample from the third substancedetection routine is determined.

It is to be understood that both the foregoing general description andthe following detailed description are exemplary and are intended toprovide further explanation of the disclosure claimed. The accompanyingdrawings are included to illustrate and provide a further understandingof the method and device of the disclosure. Together with thedescription, the drawings serve to explain the principles of the presentdisclosure.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a block diagram of the device for acute detection oftarget substance in accordance with one embodiment of the presentdisclosure;

FIG. 2 is a flowchart illustrating acute detection algorithm executed bythe device of in FIG. 1 accordance with one embodiment;

FIG. 3 is a flowchart illustrating acute detection algorithm executed bythe device of FIG. 1 in accordance with another embodiment; and

FIG. 4 is a flowchart illustrating acute detection algorithm executed bythe device of FIG. 1 in accordance with another embodiment.

DETAILED DESCRIPTION

As summarized above and as described in further detail below, inaccordance with various embodiments of the present disclosure, there areprovided methods, devices, systems and kits for acute detection oftarget substance in one or more samples including, for example, oralfluid sample and/or exhaled breath.

In certain embodiments, the detection device is configured to receive afirst sample from a sample source of a person such as oral fluid orexhaled breath, and to analyze the received sample to determine presenceof a first substance, and to receive a second sample from the sameperson, and to analyze the received second sample to determine thepresence of a second substance. In certain embodiments, when thedetection device determines that the first substance is present in thefirst sample, and further, the second substance is present in the secondsample, the detection device generates an indication or a signalassociated with the confirmation of target substance presence in thesample source of the person. In certain embodiments, the first and thesecond samples are different samples such as oral fluid and exhaledbreath. In certain embodiments, the first and the second samples are thesame type of samples such as oral fluid or exhaled breath.

In certain embodiments, the detection device is programmed to analyzethe first sample and the second sample concurrently. In certainembodiments, the second sample is acquired or received a predeterminedtime period after the first sample is acquired or received. For example,the second sample may be received within 5 minutes of receiving thefirst sample. In other embodiments, the second sample may be receivedwithin 10 minutes, within 15 minutes, within 20 minutes, within 25minutes, within 30 minutes or more after receiving the first sample. Incertain embodiments, the detection device is programmed to analyze thesecond sample differently based on when the second sample is receivedrelative to when the first sample is received, in order to determine thepresence of the first or the second substance for acute detection of thetarget substance.

In certain embodiments, the detection device is configured to receive,process and analyze one or more samples received to determine a relativegradient in the level of substance detected in the one or more samplesreceived, for acute detection of the target substance. For example, incertain embodiments, the detection device is configured to analyze thesamples to determine the substance levels over a predetermined timeperiod such as 15 minutes, 20 minutes, 25 minutes, 30 minutes, orgreater than 30 minutes, for example, to identify the presence of arelative gradient or slope over the predetermined time period, toconfirm acute presence of the target substance. In certain embodiments,the detection device, for a particular substance under detection, isprogrammed to confirm acute detection of the target substance when apositive gradient is determined over a specific time period. In otherembodiments, the detection device is programmed to confirm acutedetection of the target substance when a positive gradient is determinedover a first time period, and a negative gradient is determined over asecond time period. In certain embodiments, the first time periodprecedes the second time period. In certain embodiments, the first timeperiod is shorter than the second time period.

In certain embodiments, the detection device uses different samplingtechniques depending upon the type of sample received, such as one ormore of mass spectrometry, gas chromatography mass spectrometry, highpressure mass spectrometry, liquid chromatography mass spectrometry, ortwo dimensional gas chromatography mass spectrometry, for example, asdescribed in US Patent No. 7, 790,400, US Patent No. 8,518,653, USPatent No. 8,525,111, US Patent Publication No. 2012/0302907, and USPatent Publication No. 2012/0302907, disclosures of each of which areincorporated by reference for all purposes.

FIG. 1 illustrates a block diagram of the device for acute detection oftarget substance in accordance with one embodiment of the presentdisclosure. Referring to FIG. 1 , detection device 100 in certainembodiments includes a controller or processing unit 110 operativelycoupled to data storage 150 and an input unit 120 and an output unit130. In certain embodiments, processing unit 110 includes, but notlimited to, one or more microprocessors, application specific integratedcircuit (ASIC), single core processor, multi core processors, system ona chip (SoC) or any other data processing unit that is configured orprogrammed to execute one or more algorithms or programs to execute oneor more functions. Referring back to FIG. 1 , input unit 120 in certainembodiment includes one or more buttons, keyboards, keypads,touch-sensitive screen, pressure sensitive screen or any other inputunit for inputting data or command for detection by the processing unit110 for execution.

In certain embodiments, output unit 130 includes a visual display (forexample, a screen, a touch sensitive screen, a color screen, a bit mapscreen or any other display component for displaying information), anaudible output unit (for example, a speaker), a tactile output unit, orany other output component that is configured to output visual, tactile,audible, or a combination of such outputs, generated, for example, butthe processing unit 110. Referring still to FIG. 1 , data storage 150 incertain embodiments includes one or more of random access memory (RAM),read-only memory (ROM), electrically erasable programmable random accessmemory (EEPROM), flash memory, or any other types or variations ofvolatile memory or non-volatile memory.

In certain embodiments, detection device includes data communicationunit 160 operatively coupled to the processing unit 110 for datacommunication. In certain embodiments, data communication unit 160includes physical ports such as mini-USB ports, USB ports, RS-232 portsor any other wired connection ports to support data transfer orcommunication between the detection device and other device such as apersonal computer, a mobile telephone, a tablet computing device, aserver terminal, and/or with data network such as, for example, a publicdata network, a secured data network, a cloud data network, and thelike. In other embodiments, the data communication unit 160 includeswireless data ports such as Bluetooth data ports, infrared data ports,RF communication ports, near field communication data ports, and thelike. In certain embodiments, detection device does not include the datacommunication unit 160 and/or the analyzed data are stored in the datastorage 150 of the detection device 100.

In certain embodiments, the detection device 100 is configured tocommunicate with the one or more other devices and/or one or more datanetworks for data transfer, device software upgrade, programming ofdetection device 100 (such as, for example, receiving or downloadingpredetermined gradient profiles for target substances of interest foranalysis by the detection device 100.

Referring back to FIG. 1 , in certain embodiments, detection device 100includes one or more sampling modules 140A, 140B. For example, incertain embodiments, detection device 100 includes one sampling module140A. In other embodiments, detection device 100 includes two or moresampling modules 140A, 140B, etc. In such embodiments where multiplesampling modules 140A, 140B etc. are provided in the detection device100, the processing unit 110 is configured to execute samplingalgorithms to operate the sampling modules 140A, 140B, etc., such thateach of the plurality of sampling modules 140A, 140B, etc. performssampling routines that are the same or different sampling routines fromeach other.

In certain embodiments sample modules 140A, 140B are single usereplaceable cartridges that mate with the housing of the detectiondevice 100 and are discarded or retained for evidentiary purposes aftereach use. The housing of the detection device 100 in certain embodimentsis configured to releasably mate with the housing of the cartridge sothat the cartridge can be easily and readily replaced after each use.Further, in certain embodiments, the single use cartridge includes aninlet such as an inlet vent that is configured to receive breath samplesby having a person exhale into the inlet vent of the cartridge, and thecartridge retain the breath sample for analysis. In certain embodiments,the single use cartridge includes sample acquisition areas around orproximate to the inlet vent to acquire saliva sample when the personplaces his or her mouth around the inlet vent to exhale. In suchconfigurations, both breath sample and saliva sample are acquired fromthe single use cartridge.

In certain embodiments, processing unit 110 is configured to detect thetype of sample (oral fluid, exhaled breath etc.), and based on thedetected sample type, retrieve the suitable sampling algorithm tooperate the sampling modules. For example, in certain embodiments,sampling module 140A and sampling module 140B are configured to performone of mass spectrometry, gas chromatography mass spectrometry, highpressure mass spectrometry, liquid chromatography mass spectrometry, ortwo-dimensional gas chromatography mass spectrometry on the receivedsample, under the control of the processing unit 110. In certainembodiments, the detection device includes multiple sampling modules140A, 140B, both programmed to perform the same type of samplingprocedure.

In this manner, in certain embodiments, detection device 100 isconfigured to receive one or more same or different type of samples, andperform analysis on the received one or more samples using the same ordifferent sampling techniques to detect one or plural substances. Upondetection of the one or more substances, detection device 100 in certainembodiments is configured to generate an output signal (visual, audible,vibratory, or one or more combinations thereof), confirming acutedetection of the target substance. In certain embodiments, targetsubstance includes one or more of cannabis, alcohol, codeine, cocaine,morphine, methamphetamine, or other substance of abuse. In certainembodiments, substances for detection in the samples include one or moreof cannabinoid including tetrahydrocannabinol (THC), cannabinol (CBN),11-Hydroxy-Δ⁹-tetrahydrocannabinol (11OH-THC), 11-nor-9-Carboxy-THC(THC-COOH), alcohol, codeine, cocaine, morphine, methamphetamine, orother substance of abuse or its metabolites.

In certain embodiments, the processing unit 110 confirms the presence ofdetectable substances based on the sample analysis when a predeterminedamount of the substance is detected in the sample, for example, inmicrogram, nanogram or picogram range or level. Upon detectionconfirmation of the detectable substance, in certain embodiments,processing unit 110 confirms acute presence of target substance. Forexample, in certain embodiments, the processing unit 110 of thedetection device 100 is configured to provide a positive indication ofacute detection of cannabis based on detection of one or moremetabolites of cannabis such as 11-OH-THC or THC-COOH. In certainembodiments, processing unit 110 analyzes temporally spaced sampleacquisition, and determines one or more gradients of the detectablesubstance level based on sample analysis, based upon which theprocessing unit confirms acute presence of target substance.

FIG. 2 is a flowchart illustrating acute detection algorithm executed bythe device of FIG. 1 in accordance with one embodiment. Referring toFIG. 2 , in certain embodiments, the first sample under analysis isacquired (210) by sampling module 140A and analyzed (220) by theprocessing unit 110 operatively coupled to the sampling module 140A. Theprocessing unit 110 determines whether the first substance is detectedin the first sample (230), and if not, the routine returns to analyzethe first sample (220) again. Concurrent with the acquisition of thefirst sample (210), a second sample is acquired by sampling module 140B(240) and analyzed (250) by the processing unit 110 that is operativelycoupled to the second sampling module 140B. The processing unitdetermines whether the second substance is detected in the second sample(260), and if not, the routine returns to analyze the second sampleagain (250).

Referring back to FIG. 2 , when the processing unit 110 determines thatthe first substance is detected (230) and the second substance isdetected (260), in certain embodiments, the processing unit 110generates one or more signals indicating acute detection of targetsubstance (270), and outputs an indication at the output unit (130)corresponding to the acute detection of the target substance. In certainembodiments, the second sample is acquired after the first sample, suchthat the processing unit 110 is configured to perform the acquisition(240), analysis (250) and detection of the second substance (260) in thefirst sample, after the processing unit 110 has performed acquisition(210), analysis (220) and detection of the first substance (230) in thefirst sample. In further embodiments, the source of the first sample andthe second sample are the same such that the same or similar samplingtechniques are used by the sampling module 140A and sampling module 140Bunder the control of the processing unit 110. Further, in still otherembodiments, additional samples may be acquired, analyzed and processedfor detection of additional substances.

In certain embodiments, the first and second substances are the samesubstances having the same or similar chemical composition orcharacteristics. In other embodiments, the first and second substancesfor detection may be related but different substances. For example, incertain embodiments, the first substance for detection is THC and thesecond substance for detection is a metabolite of THC such as, forexample, 11-OH-THC. In certain embodiments, the first substance fordetection is a first metabolite of THC such as, for example, THC-COOH,and the second substance for detection is a second metabolite of THCsuch as, for example, 11-OH-THC. In still further embodiments, the firstsubstance for detection is THC and the second substance for detection isalcohol. In still further embodiments, the first substance for detectionis THC and the second substance for detection is alcohol whereby theacute detection of target substance (270) includes detection of bothcannabis and alcohol as target substances. In yet still furtherembodiments, the first substance for detection is THC and the secondsubstance for detection is one or more of codeine, cocaine, morphine,methamphetamine, or other substance of abuse.

FIG. 3 is a flowchart illustrating acute detection algorithm executed bythe device of FIG. 1 in accordance with another embodiment. Referring toFIG. 3 , in certain embodiments, first sample for a sample source suchas oral fluid or exhaled breath is acquired by sampling module 140A(310) and analyzed (320). After a predetermined time from theacquisition of the first sample (for example, after 5 minutes, or 10minutes, or 15 minutes, or 20 minutes, 25 minutes or 30 minutes orgreater), a second sample from the same sample source is acquired (330)and analyzed (340).

After analysis of the first and second samples, a gradient is determinedin certain embodiments by the processing unit 110 based on thedifference between the level of substance detected in the first sampleand the level of substance detected in the second sample (350). When thedetermined gradient corresponds to a predetermined gradient profile,processing unit 110 is configured to generate one or more signalscorresponding to acute detection of target substance (360). For example,in certain embodiments, the gradient profile includes a positive slopebetween the level of detected first substance and the level of detectedsecond substance. In certain embodiments, the gradient profile includesa negative slope. Within the scope of the present disclosure, thegradient profile corresponding to the acute detection of targetsubstance may vary depending upon the target substance for acutedetection. In certain embodiments, one or more gradient profiles may bestored in the data storage unit 150 which is retrieved by the processingunit 110 for comparison with the generated or determined gradient basedon the levels of first and second substances, and/or based on thehalf-life data or profile of the target substance and/or the first andsecond substances.

FIG. 4 is a flowchart illustrating acute detection algorithm executed bythe device of FIG. 1 in accordance with another embodiment. Referring toFIG. 4 , samples are acquired and analyzed for detection of therespective substances (410-460) similar to the corresponding routinesdiscussed above in conjunction with steps 210-260 of FIG. 2 . Asdiscussed above, the sample acquisitions (410, 440) may be concurrentlyperformed, or serially performed such that the one of the two samples isacquired after the other of the two samples. Referring back to FIG. 4 ,after the detection of the substances for analysis, the processing unit110 determines a gradient based on the level of the detected substances.Similar to the gradient analysis discussed above in conjunction withFIG. 3 , the processing unit 110 generates one or more signalsindicating acute detection of the target substance when the determinedone or more gradients correspond to or matches with the one or moregradient profiles for the substances under analysis.

Referring back to FIG. 4 , in certain embodiments, detection device 100is configured to acquire sample (410) under analysis by sampling module140A and analyzed (420) by the processing unit 110 operatively coupledto the sampling module 140A. The processing unit 110 determines whetherthe substance is detected in the sample (430), and if not, the routinereturns to analyze the sample (420) again. In certain embodiments, theprocessing unit 110 determines the presence and the level of thedetected substance in the sample (430). After a predetermined amount oftime from detection and determination of the level of the substance(430), the detection device 100 in certain embodiments performs sampleacquisition (410), sample analysis (420) and substance detection (430)routines again to determine the level of the detected substance inanother sample. In certain embodiments, processing unit 100 isconfigured to perform the sub-routines 410-430 two or more times todetermine two or more levels of detected substance under analysis (470)which is used to determine a gradient based on the analysis of thesamples. The determined gradient in certain embodiments is used forcomparison to a predetermined gradient profile of the substance underanalysis to confirm acute detection of target substance (480).

As discussed above, one or more of the sub-routines 410-430 may berepeated until the detection device 100 confirms the detection of thesubstance (430) to generate multiple levels of detected substance.Referring back to FIG. 4 , in certain embodiments, another sample isacquired by sampling module 140B (440) and analyzed (450) by theprocessing unit 110 that is operatively coupled to the second samplingmodule 140B. The processing unit 100 determines whether the substance isdetected in the other sample (460), and if not, the routine returns toanalyze the other sample (450) again. In certain embodiments, theprocessing unit 110 determines the presence and the level of thedetected substance in the other sample (460). After a predeterminedamount of time from detection and determination of the level of thesubstance (460), the detection device 100 in certain embodimentsperforms sample acquisition (440) of the other sample, sample analysis(450) and substance detection (460) routines again to determine thelevel of the detected substance in the other sample. In certainembodiments, processing unit 100 is configured to perform thesub-routines 410-430 two or more times to determine two or more levelsof detected substance under analysis (470) which is used to determine agradient based on the analysis of the samples. The determined gradientin certain embodiments is used for comparison to a predeterminedgradient profile of the substance under analysis to confirm acutedetection of target substance (480).

In certain embodiments, the detection device 100 detects the presenceand the levels of THC and the presence and the levels of its metabolitesuch as, for example, but not limited to, 11-OH-THC, and thereafter,performs the gradient analysis to confirm acute detection of cannabis inthe samples providing a positive indication of cannabis use within apredetermined time from the sample acquisition (for example, within 1-2hours before sample acquisition, less than an hour before sampleacquisition, within 2-3 hours before sample acquisition, within 3-4hours of sample acquisition, within 4-5 hours of sample acquisition, orwithin 8 hours of sample acquisition).

Accordingly, in certain embodiments, there is provided a methodincluding performing acquisition of a sample having a plurality ofanalysis substances, executing, using one or more processors, a firstsubstance detection routine and a second substance detection routine fordetecting the presence of the first analysis substance and the secondanalysis substance in the acquired sample, respectively; and generatingan output signal based on the executed first and second substancedetection routines, wherein the output signal corresponds to the acutedetection of target substance in the sample.

The sample in certain embodiments includes oral fluid sample.

The sample in certain embodiments includes exhaled breath sample.

The sample in certain embodiments includes a combination of oral fluidsample and exhaled breath sample.

In certain embodiments, the first substance detection routine and thesecond substance detection routine are performed simultaneously.

In certain embodiments, the first substance detection routine and thesecond substance detection routine are performed sequentially.

In certain embodiments, the target substance include cannabis.

In certain embodiments, the plurality of analysis substances includescannabinoid and one or more metabolites of cannabinoids. Further, incertain embodiments, the cannabinoid includes tetrahydrocannabinol (THC)and further, wherein the one or more metabolites includes cannabinol(CBN), 11-Hydroxy-Δ⁹-tetrahydrocannabinol (11-OH-THC), or11-nor-9-Carboxy-THC (THC-COOH).

In certain embodiments, the output signal corresponds to acute presenceof the target substance in the acquired sample indicating exposure ofthe sample to the target substance within a predetermined time periodprior to obtaining the sample. Further, in certain embodiments, thepredetermined time period includes one or more of less than 30 minutesfrom sample acquisition, between 30 minutes to one hour from sampleacquisition, between one hour and two hours from sample acquisition,between two hours and three hours from sample acquisition, between threehours and four hours from sample acquisition, or more than four hoursfrom sample acquisition.

In certain embodiments, the sample acquisition is performed using one ormore of mass spectrometry, gas chromatography mass spectrometry, highpressure mass spectrometry, liquid chromatography mass spectrometry, ortwo dimensional gas chromatography mass spectrometry.

A method in accordance with another embodiment includes performingacquisition of a sample having one or more analysis substances,executing, using one or more processors, a first substance detectionroutine and a second substance detection routine for detecting thepresence of the first analysis substance and the second analysissubstance in the acquired sample, respectively, generating an outputsignal based on the executed first and second substance detectionroutines, wherein the output signal corresponds to the presence in thesample of target substance associated with the one or more of theanalysis substances, where the second substance detection routine isperformed within a predetermined time period after the completion of thefirst substance detection routine, where the first analysis substance isthe same as the second analysis substance, and further, where the outputsignal confirms the acute detection of the target substance in theacquired sample when a determined gradient corresponds to apredetermined gradient, where the gradient is determined based on thelevel of the detected first analysis substance and the detected secondanalysis substance.

The sample in certain embodiments includes oral fluid sample.

The sample in certain embodiments includes exhaled breath sample.

The sample in certain embodiments includes a combination of oral fluidsample and exhaled breath sample.

In certain embodiments, the first substance detection routine and thesecond substance detection routine are performed simultaneously.

In certain embodiments, the first substance detection routine and thesecond substance detection routine are performed sequentially.

In certain embodiments, the target substance include cannabis.

In certain embodiments, the plurality of analysis substances includescannabinoid and one or more metabolites of cannabinoids. Further, incertain embodiments, the cannabinoid includes tetrahydrocannabinol (THC)and further, wherein the one or more metabolites includes cannabinol(CBN), 11-Hydroxy-Δ⁹-tetrahydrocannabinol (11-OH-THC), or11-nor-9-Carboxy-THC (THC-COOH).

In certain embodiments, the output signal corresponds to acute presenceof the target substance in the acquired sample indicating exposure ofthe sample to the target substance within a predetermined time periodprior to obtaining the sample. Further, in certain embodiments, thepredetermined time period includes one or more of less than 30 minutesfrom sample acquisition, between 30 minutes to one hour from sampleacquisition, between one hour and two hours from sample acquisition,between two hours and three hours from sample acquisition, between threehours and four hours from sample acquisition, or more than four hoursfrom sample acquisition.

In certain embodiments, the sample acquisition is performed using one ormore of mass spectrometry, gas chromatography mass spectrometry, highpressure mass spectrometry, liquid chromatography mass spectrometry, ortwo dimensional gas chromatography mass spectrometry.

A method in still a further embodiment includes performing acquisitionof a sample having one or more analysis substances, executing, using oneor more processors, a first substance detection routine for detectingthe presence of the first analysis substance, a second substancedetection routine for detecting the presence of the first analysissubstance, and a third substance detection routine for detecting thepresence of the second analysis substance, and generating an outputsignal based on the executed first, second and third substance detectionroutines, wherein the output signal corresponds to the presence in thesample of target substance associated with the one or more of theanalysis substances, where the second substance detection routine isperformed within a predetermined time period after the completion of thefirst substance detection routine and further where the output signalconfirms acute detection of the target substance in the acquired samplewhen (1) a determined gradient of the first analysis substancecorresponds to a predetermined gradient profile, where the gradient isdetermined based on the level of the detected first analysis substancefrom the first substance detection routine and the second substancedetection routine, and (2) the presence of the second analysis substanceassociated with the target sample from the third substance detectionroutine is determined.

The sample in certain embodiments includes oral fluid sample.

The sample in certain embodiments includes exhaled breath sample.

The sample in certain embodiments includes a combination of oral fluidsample and exhaled breath sample.

In certain embodiments, the first substance detection routine and thesecond substance detection routine are performed simultaneously.

In certain embodiments, the first substance detection routine and thesecond substance detection routine are performed sequentially.

In certain embodiments, the target substance include cannabis.

In certain embodiments, the plurality of analysis substances includescannabinoid and one or more metabolites of cannabinoids. Further, incertain embodiments, the cannabinoid includes tetrahydrocannabinol (THC)and further, wherein the one or more metabolites includes cannabinol(CBN), 11-Hydroxy-Δ⁹-tetrahydrocannabinol (11-OH-THC), or11-nor-9-Carboxy-THC (THC-COOH).

In certain embodiments, the output signal corresponds to acute presenceof the target substance in the acquired sample indicating exposure ofthe sample to the target substance within a predetermined time periodprior to obtaining the sample. Further, in certain embodiments, thepredetermined time period includes one or more of less than 30 minutesfrom sample acquisition, between 30 minutes to one hour from sampleacquisition, between one hour and two hours from sample acquisition,between two hours and three hours from sample acquisition, between threehours and four hours from sample acquisition, or more than four hoursfrom sample acquisition.

In certain embodiments, the sample acquisition is performed using one ormore of mass spectrometry, gas chromatography mass spectrometry, highpressure mass spectrometry, liquid chromatography mass spectrometry, ortwo dimensional gas chromatography mass spectrometry.

An apparatus in accordance with one embodiment includes one or moresampling modules configured to acquire one or more samples having one ormore analysis substances, a processing unit operatively coupled to theone or more sampling modules configured to execute a first substancedetection routine and a second substance detection routine for detectingthe presence of the first analysis substance and the second analysissubstance in the acquired one or more samples, respectively, and anoutput unit operatively coupled to the processing unit and configured tooutput one or more signals based on the executed first and secondsubstance detection routines, wherein the output signal corresponds toacute detection of target substance in the one or more samples.

In certain embodiments, the sample includes oral fluid sample.

In certain embodiments, the sample includes exhaled breath sample.

In certain embodiments, the sample includes a combination of oral fluidsample and exhaled breath sample.

In certain embodiments, the processing unit is configured to perform thefirst substance detection routine and the second substance detectionroutine simultaneously.

In certain embodiments, the processing unit is configured to perform thefirst substance detection routine and the second substance detectionroutine sequentially.

In certain embodiments, the target substance or substances includecannabis, alcohol, or cannabis and alcohol.

In certain embodiments, the plurality of analysis substances includescannabinoid and one or more metabolites of cannabinoids. Further, incertain embodiments, the cannabinoid includes tetrahydrocannabinol (THC)and further, wherein the one or more metabolites includes cannabinol(CBN), 11-Hydroxy-Δ⁹-tetrahydrocannabinol (11-OH-THC), or11-nor-9-Carboxy-THC (THC-COOH).

In certain embodiments, the output signal corresponds to acute presenceof the target substance in the acquired sample indicating exposure ofthe sample to the target substance within a predetermined time periodprior to obtaining the sample.

In certain embodiments, the predetermined time period includes one ormore of less than 30 minutes from sample acquisition, between 30 minutesto one hour from sample acquisition, between one hour and two hours fromsample acquisition, between two hours and three hours from sampleacquisition, between three hours and four hours from sample acquisition,or more than four hours from sample acquisition.

In certain embodiments, the first substance detection routine and thesecond substance detection routine are performed using one or more ofmass spectrometry, gas chromatography mass spectrometry, high pressuremass spectrometry, liquid chromatography mass spectrometry, or twodimensional gas chromatography mass spectrometry.

In certain embodiments, the one or more sampling module includes asingle use disposable cartridge.

An apparatus in accordance with still yet further embodiment includesone or more sampling modules configured to acquire one or more sampleshaving one or more analysis substances, a processing unit operativelycoupled to the one or more sampling modules configured to execute afirst substance detection routine and a second substance detectionroutine for detecting the presence of the first analysis substance andthe second analysis substance in the acquired sample, respectively togenerate one or more signals based on the executed first and secondsubstance detection routines, wherein the generated one or more signalscorresponds to acute detection· of target substance in the one or moresamples, where the second substance detection routine is performedwithin a predetermined time period after the completion of the firstsubstance detection routine, where the first analysis substance is thesame as the second analysis substance, and further, where the one ormore signals confirms the acute detection of the target substance in theacquired sample when a determined gradient corresponds to apredetermined gradient, where the gradient is determined based on thelevel of the detected first analysis substance and the detected secondanalysis substance.

In certain embodiments, the sample includes oral fluid sample.

In certain embodiments, the sample includes exhaled breath sample.

In certain embodiments, the sample includes a combination of oral fluidsample and exhaled breath sample.

In certain embodiments, the processing unit is configured to perform thefirst substance detection routine and the second substance detectionroutine simultaneously.

In certain embodiments, the processing unit is configured to perform thefirst substance detection routine and the second substance detectionroutine sequentially.

In certain embodiments, the target substance or substances includecannabis, alcohol, or cannabis and alcohol.

In certain embodiments, the plurality of analysis substances includescannabinoid and one or more metabolites of cannabinoids. Further, incertain embodiments, the cannabinoid includes tetrahydrocannabinol (THC)and further, wherein the one or more metabolites includes cannabinol(CBN), 11-Hydroxy-Δ⁹-tetrahydrocannabinol (11-OH-THC), or11-nor-9-Carboxy-THC (THC-COOH).

In certain embodiments, the output signal corresponds to acute presenceof the target substance in the acquired sample indicating exposure ofthe sample to the target substance within a predetermined time periodprior to obtaining the sample.

In certain embodiments, the predetermined time period includes one ormore of less than 30 minutes from sample acquisition, between 30 minutesto one hour from sample acquisition, between one hour and two hours fromsample acquisition, between two hours and three hours from sampleacquisition, between three hours and four hours from sample acquisition,or more than four hours from sample acquisition.

In certain embodiments, the first substance detection routine and thesecond substance detection routine are performed using one or more ofmass spectrometry, gas chromatography mass spectrometry, high pressuremass spectrometry, liquid chromatography mass spectrometry, or twodimensional gas chromatography mass spectrometry.

In certain embodiments, the one or more sampling module includes asingle use disposable cartridge.

An apparatus in yet still a further embodiment includes one or moresampling modules configured to acquire one or more samples having one ormore analysis substances, a processing unit operatively coupled to theone or more sampling modules configured to execute a first substancedetection routine for detecting the presence of the first analysissubstance, a second substance detection routine for detecting thepresence of the first analysis substance, and a third substancedetection routine for detecting the presence of the second analysissubstance, the processing unit further configured to generate an outputsignal based on the executed first, second and third substance detectionroutines, wherein the output signal corresponds to acute detection oftarget substance in the one or more samples, where the second substancedetection routine is performed within a predetermined time period afterthe completion of the first substance detection routine, and furtherwhere the output signal confirms acute detection of the target substancein the acquired sample when (1) a determined gradient of the firstanalysis substance corresponds to a gradient profile, where the gradientis determined based on the level of the detected first analysissubstance from the first substance detection routine and the secondsubstance detection routine, and (2) the presence of the second analysissubstance associated with the target sample from the third substancedetection routine is determined.

In certain embodiments, the sample includes oral fluid sample.

In certain embodiments, the sample includes exhaled breath sample.

In certain embodiments, the sample includes a combination of oral fluidsample and exhaled breath sample.

In certain embodiments, the processing unit is configured to perform thefirst substance detection routine and the second substance detectionroutine simultaneously.

In certain embodiments, the processing unit is configured to perform thefirst substance detection routine and the second substance detectionroutine sequentially.

In certain embodiments, the target substance or substances includecannabis, alcohol, or cannabis and alcohol.

In certain embodiments, the plurality of analysis substances includescannabinoid and one or more metabolites of cannabinoids. Further, incertain embodiments, the cannabinoid includes tetrahydrocannabinol (THC)and further, wherein the one or more metabolites includes cannabinol(CBN), 11-Hydroxy-Δ⁹-tetrahydrocannabinol (11-OH-THC), or11-nor-9-Carboxy-THC (THC-COOH).

In certain embodiments, the output signal corresponds to acute presenceof the target substance in the acquired sample indicating exposure ofthe sample to the target substance within a predetermined time periodprior to obtaining the sample.

In certain embodiments, the predetermined time period includes one ormore of less than 30 minutes from sample acquisition, between 30 minutesto one hour from sample acquisition, between one hour and two hours fromsample acquisition, between two hours and three hours from sampleacquisition, between three hours and four hours from sample acquisition,or more than four hours from sample acquisition.

In certain embodiments, the first substance detection routine and thesecond substance detection routine are performed using one or more ofmass spectrometry, gas chromatography mass spectrometry, high pressuremass spectrometry, liquid chromatography mass spectrometry, or twodimensional gas chromatography mass spectrometry.

In certain embodiments, the one or more sampling module includes asingle use disposable cartridge.

It will be apparent to those skilled in the art that variousmodifications and alterations in the methods, devices, and systems ofthe present disclosure will be apparent to those skilled in the artwithout departing from the scope and spirit of the present disclosure.Although the present disclosure has been described in connection withspecific embodiments, it should be understood that the presentdisclosure as claimed should not be unduly limited to such specificembodiments. It is intended that the following claims define the scopeof the present disclosure and that structures and methods within thescope of these claims and their equivalents be covered thereby.

What is claimed is:
 1. A method comprising: controlling acquisition of afirst sample; detecting a type of the first sample, including detectingwhether the first sample is a breath sample type or an oral fluid sampletype; determining an algorithm or program that is suitable for the typeof the first sample; and executing the algorithm or program to processthe first sample.
 2. The method of claim 1, wherein executing thealgorithm or program includes include using at least one of massspectrometry, gas chromatography mass spectrometry, high pressure massspectrometry, liquid chromatography mass spectrometry, ortwo-dimensional gas chromatography mass spectrometry.
 3. The method ofclaim 2, wherein executing the algorithm or program includes detectingany one of multiple substances.
 4. The method of claim 2, wherein themultiple substances include one or more substances that are indicativeof a controlled substance.
 5. The method of claim 4, wherein thecontrolled substance includes THC.
 6. The method of claim 1, whereincontrolling acquisition of the first sample includes receiving the firstsample from an inlet valve or an area surrounding the inlet valve. 7.The method of claim 1, wherein the first sample is acquired using afirst test cartridge, and wherein the method further comprisescontrolling acquisition of a second sample using a second testcartridge.
 8. The method of claim 1, wherein the first sample isacquired using a first test cartridge, and wherein the method furthercomprises controlling acquisition of a second sample using the firsttest cartridge.
 9. The method of claim 1, wherein the method furthercomprises generating an output based on a determination of the executedalgorithm or program.
 10. An apparatus comprising: a housing; aprocessing unit configured to: control acquisition of a first sample;detect a type of the first sample, including detecting whether the firstsample is a breath sample type or an oral fluid sample type; determinean algorithm or program that is suitable for the type of the firstsample; and execute the algorithm or program to process the firstsample.
 11. The apparatus of claim 10, wherein the processor isconfigured to execute the algorithm or program includes include using atleast one of mass spectrometry, gas chromatography mass spectrometry,high pressure mass spectrometry, liquid chromatography massspectrometry, or two-dimensional gas chromatography mass spectrometry.12. The apparatus of claim 11, wherein the processing unit is configuredto execute the algorithm or program to detect any one of multiplesubstances.
 13. The apparatus of claim 12, wherein the multiplesubstances include one or more substances that are indicative of acontrolled substance.
 14. The apparatus of claim 13, wherein thecontrolled substance includes THC.
 15. The apparatus of claim 10,wherein the first sample is received from an inlet valve or an areasurrounding the inlet valve.
 16. The apparatus of claim 10, wherein thefirst sample is acquired using a first test cartridge, and wherein theprocessor is further configured to control acquisition of a secondsample using a second test cartridge.
 17. The apparatus of claim 10,wherein the first sample is acquired using a first test cartridge, andwherein the processing unit is further configured to control acquisitionof a second sample using the first test cartridge.
 18. The apparatus ofclaim 10, wherein the processing unit is further configured to generatean output based on a determination of the executed algorithm or program.19. A test cartridge comprising: an inlet to receive a first sample of abreath sample type; a sample acquisition area to receive a second samplethat is an oral fluid sample type; wherein the test cartridge is matablewith a housing of a second device to process at least one of the firstsample or the second sample.
 20. The test cartridge of claim 19, whereinthe test cartridge is single use.